MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in japan as follows: device report from depuy synthes reports an event in japan as follows: it was reported on (b)(6) 2018 the patient underwent a primary procedure (l3-s) and 7.0mm (diameter) screws were applied.On an unknown date, it was found that the screw at l3 had been loose.The 2nd procedure (1st removal) was done on (b)(6) 2018 to remove the loose screw and deploy a replacing screw (10mm in diameter).Also, the fusion was extended up to l1.Screws (7 x 40mm) were applied to l1 and l2.This report captures the first removal procedure which was performed on (b)(6) 2018 due to loose screw, while related complaint (b)(4) captures the second hardware removal procedure which was performed on (b)(6) 2022 due to screws backing out.This report is for one (1) unknown screw.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SCREWS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15312557
• MDR Text Key: 298809265
• Report Number: 1526439-2022-01488
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male